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Completed

NCT Number: NCT04031807

Risk Factors for Failure After Single-incision Sling Procedure in Women With Stress Urinary Incontinence

The main risk factors for failure after single-incision slings are reduced urethral mobility and stress urinary incontinence severity in long-term follow-up.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

37 year–78 year

Sex eligibility

Female

Study type

Observational

Primary location

Maltepe University Faculty of Medicine

Istanbul, 34844, Turkey (Türkiye)

About this study

The medical records of the 132 patients were retrospectively analyzed. Preoperative assessment included medical history and urogynecological examination. Patients were asked to answer validated questionnaires such as Urinary Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7). Objective cure of SUI was defined as the absence of demonstrable leakage of urine on the cough stress test. Subjective cure was based on negative response to UDI-6, question 3. Patients were divided according to objective cure rate into two groups: cured (Group A) and failed patients (Group B).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women who underwent single-incision sling procedure for stress urinary incontinence

Exclusion criteria

Urodinamically proven detrusor overactivity

Neurogenic bladder

Previous anti-incontinence surgery including midurethral slings

Postvoidal residual volume (PVR) >100mL

Previous radical pelvic surgery

Anterior pelvic organ prolapse greater than stage I

Treatment and study plan

Single-Incision Sling

Procedure

The women with stress urinary incontinence underwent single-incision sling procedure.

Primary outcomes

  1. objective cure

    Time frame: September 2009 to September 2017

    negative cough stress test

Secondary outcomes

  1. subjective cure

    Time frame: September 2009 to September 2017

    negative response to Urinary Distress Inventory (UDI-6), question 3.

Sponsors and collaborators

Lead sponsor

Maltepe University

Other

Registry information

Official study title

Risk Factors for Failure After Single-incision Sling Procedure. Retrospective Analysis of 132 Women

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 24, 2019
Registry last updated
Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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